ZUBSOLV 8.6/2.1 buprenorphine (as HCl) 8.6 mg / naloxone (as HCl dihydrate) 2.1 mg sublingual tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

buprenorphine hydrochloride,naloxone hydrochloride dihydrate

Available from:

AA-Med Pty Ltd

Authorization status:

Registered

Patient Information leaflet

ZUBSOLV® SUBLINGUAL TABLET
1
ZUBSOLV
®
SUBLINGUAL TABLET
_buprenorphine (as hydrochloride) / naloxone (as hydrochloride
dihydrate)_
CONSUMER MEDICINE INFORMATION
WARNING:
HAZARDOUS AND HARMFUL USE
ZUBSOLV poses risks of abuse and misuse which can lead to overdose and
death. Your doctor will monitor you regularly
during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
ZUBSOLV can cause life-threatening or fatal breathing problems (slow,
shallow, unusual or no breathing) even when used as
recommended. These problems can occur at any time during use, but the
risk is higher when first starting ZUBSOLV and after a
dose increase, if you are older or if you have an existing problem
with your lungs. Your doctor will monitor you and change the
dose as appropriate.
USE OF OTHER MEDICINES WHILE USING ZUBSOLV
Using ZUBSOLV with other medicines that can make you feel drowsy such
as sleeping tablets (e.g. benzodiazepines), other
pain relievers, antihistamines, antidepressants, antipsychotics,
gabapentinoids (e.g. gabapentin and pregabalin), cannabis and
alcohol may result in severe drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will minimise
the dose and duration of use; and monitor you for signs and symptoms
of breathing difficulties and sedation. You must not drink
alcohol while using ZUBSOLV.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about ZUBSOLV. It does not
contain all the available information. It does not take
the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking ZUBSOLV against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS ZUBSOLV USED FOR?
ZUBSOLV is used to treat dependence on opioids like heroin, morphine,
oxycodone or codeine in patients who have agreed to
be treated for their addiction, who are also receiving

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ZUBSOLV
® (BUPRENORPHINE/NALOXONE)
WARNINGS
_HAZARDOUS AND HARMFUL USE _
Although ZUBSOLV is indicated for the treatment of opioid dependence
it still poses risks
of hazardous and harmful use which can lead to overdose and death.
Monitor the
patient’s ongoing risk of hazardous and harmful use regularly during
opioid substitution
therapy with ZUBSOLV (see _section 4.4. Special Warnings and
Precautions for Use_).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life‐threatening or fatal respiratory depression may occur
with the use of
ZUBSOLV. Be aware of situations which increase the risk of respiratory
depression, and
monitor patients closely, especially on initiation or following a dose
increase (see _section _
_4.4 Special Warnings and Precautions for Use_).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines,
tricyclic antidepressants, antipsychotics, cannabis or other central
nervous system (CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression,
coma, and death. Patients and their caregivers should be made aware of
the symptoms
of respiratory depression. Patients and their caregivers should also
be informed of the
potential harms of consuming alcohol while taking ZUBSOLV.
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NAME OF THE MEDICINE
ZUBSOLV contains buprenorphine (as hydrochloride) and naloxone (as
hydrochloride dihydrate) at a
ratio of 4:1 buprenorphine:naloxone (ratio of free bases).
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QUALITATIVE AND QUANTITATIVE COMPOSITION
ZUBSOLV is intended for sublingual administration. It is available in
six strengths: 0.7/0.18 mg,
1.4/0.36 mg, 2.9/0.71 mg, 5.7/1.4 mg, 8.6/2.1 mg and 11.4/2.9 mg.
Each ZUBSOLV 0.7/0.18 sublingual tablet contains 0.7 mg buprenorphine
(as hydrochloride) and
0.18 mg naloxone (as hydrochloride dihydrate).
2
Each ZUBSOLV 1.4/0.36 sublingual tablet contains 1.4 mg buprenorphine
(as hydrochloride) and
0.36 mg nalox